Representatives of Brno hospitals and IQVIA gathered on Wednesday, 19^th April 2023, to celebrate 10 years of collaboration in innovative clinical studies. Members of the Moravian Prime Site, a unique space for collaboration in the design and implementation of clinical studies, highlighted the benefits of joint activities for research, patients, and the South Moravian Region. They have also encouraged the public to participate in clinical studies, e.g. through the new registry of volunteers.

Five Moravian hospital and outpatient facilities constitute the Moravian Prime Site: St. Anne’s University Hospital in Brno (FNUSA), the Military Hospital Brno, the University Hospital Brno (FN Brno), the Masaryk Memorial Cancer Institute (MOÚ), and Medical Plus outpatient clinic in Uherské Hradiště.

“IQVIA is committed to the advancement of innovative research and development in the healthcare sector, and Moravian Prime Site is a key component of our strategy. By ensuring world class research, patients can have greater access to new therapies and transformed health outcomes in the future” says Dean Summerfield, Senior Vice President, Real World and Commercial Solutions EMEA, IQVIA.

The creation of the Prime Site followed the St Anne’s University Hospital in Brno’s (FNUSA) long-term activities in the field of clinical studies. One of the decisive factors was also the establishment of the International Clinical Research Center (ICRC) in 2011 and the related establishment of a centralized clinical studies department. The ICRC effectively connects research, academic, and applied spheres to bring modern practices from the microscope to physicians’ offices.

As the Director of FNUSA, Ing. Vlastimil Vajdák, stated: “The field of clinical and research studies is an opportunity to bring future treatment closer to patients. In addition to companies such as IQVIA, which bring studies to FNUSA, patients are our key partners, and we value their trust. I am glad that we have managed to connect with the expert teams of other Brno hospitals as well.” Collaboration between hospitals also enables the implementation of extensive studies that an individual subject would not be able to cover.

The Director of FN Brno, Ivo Rovný, MD, MBA, adds: “Clinical studies have become an integral part of patient care at individual FN Brno clinics and cover a wide range of diseases, especially in the fields of oncology and haematology, paediatric oncology, gynaecology, cardiology, neurology, and psychiatry. In some of these areas, FN Brno provides irreplaceable care within Brno and the South Moravian Region.” Thanks to its own Transfusion and Tissue Department, FN Brno can also fully participate in the implementation of studies that include medicinal products for modern therapies and can offer collaboration to other partners.

Moravian Prime Site is fulfilling other goals as well, such as supporting patient involvement in clinical trials. FNUSA has developed a registry for volunteers who want to participate in clinical trials and research. This gives the public the opportunity to contribute to research of  treatments and diagnostic methods for future generations. Other partner institutions offer similar opportunities.

“The Masaryk Memorial Cancer Institute has had a more than twenty-year tradition of clinical trials, which are fully integrated into the institute’s operations and care for our patients and remain one of our development priorities. We greatly value the long-term and deepening cooperation with major partners such as IQVIA,” says MOÚ Director, Prof. Marek Svoboda, MD, PhD. “Not only do we expand the possibilities of oncological treatment for our patients, but the field of clinical research has an international reach for MOÚ. This year, we have gained the prestigious status of the European OECI Comprehensive Cancer Center. We are also a centre of the EUCRAN network for rare solid tumours,” he adds.

Moravian Prime Site members recognized the benefits of ten years of cooperation during the meeting, streamlining the entire process of managing clinical trials and, most importantly, enrolling over 2,100 patients in conducted clinical trials. The goal is to accelerate diagnostic processes, predict disease development, and evaluate the effectiveness of new treatment methods.

 

Author: Marta Vrlová, M.A., MPH, Senior PR Specialist ICRC, marta.vrlova@fnusa.cz.

Media contacts:

• Jiří Erlebach, Head of PR and Marketing Dpt, FNUSA Spokesperson, +420 543 182 006. jiri.erlebach@fnusa.cz.
• Sorin Petcu, General Manager Czech Republic and Slovakia, IQVIA, +420 607 020 929, sorin.petcu@iqvia.com
• Václav Janištin, Head of Communications Center in FN Brno, +420 532 232 193, Janistin.Vaclav@fnbrno.cz
• Veronika Plachá, FN Brno Spokesperson, +420 532 231 387

 

About partners:

 

International Clinical Research Center (ICRC) FNUSA and LF MU

We are a modern center of scientific excellence based in Brno, focused on preclinical and clinical research, primarily in the fields of cardiology, neurology, and oncology. We are looking for new diagnostic and therapeutic methods, technologies, and medicines. By implementing our findings into practice, we improve patient care and their quality of life. In July 2022, we became a joint workplace of the Faculty Hospital of St. Anne in Brno (FNUSA) and the Faculty of Medicine of Masaryk University (LF MU) in Brno. We are developing relationships and cooperation with other key players, both internationally and within our region. Our activities are included in the action plan for the implementation of the #brno2050 strategy. We are helping to shape the future of the #brnoregion.

The Clinical Trials Center (CCS) of ICRC has been the primary contact point for clinical evaluation within FNUSA since 2009. It provides all communication between the faculty hospital and the sponsors of clinical trials or the entities authorized by the sponsor. We are also the contact point for patients participating in specific studies and those interested in being included in the volunteer database. FNUSA currently has around 160 studies running, and CCS negotiates around 40-50 new studies per year. These are studies in almost all clinics, in the fields of cardiology, neurology, and internal medicine.

You can find more information about us at fnusa-icrc.org and fnusa.cz/klinicke-studie

 

Masaryk Memorial Cancer Institute – Department of Clinical Trials

Masaryk Memorial Cancer Institute in Brno is a top specialized cancer center with supra-regional coverage, a unique healthcare facility in the Czech Republic, and as of 2023, a European OECI Comprehensive Cancer Center. It houses all necessary medical fields to provide comprehensive cancer care, including prevention, epidemiology, diagnosis, individual modalities of anti-cancer therapy, rehabilitation, and public education. The institute focuses on scientific research, including basic research.

The tradition of conducting clinical studies at the Masaryk Memorial Cancer Institute dates back to the 1970s, when the institute was a significant research partner in the development of new cytostatic. In 2000, as the first of its kind in the Czech Republic, the Department of Clinical Studies (OKS) was established, providing complete organizational, administrative, and professional support for clinical studies at MOÚ. It prepares all contractual and academic clinical evaluations, and after their initiation, a team of experienced study coordinators, study nurses, and data managers coordinates and conducts study visits according to the protocol, participates in patient recruitment, and manages data and communication with the sponsor. The department also provides training for clinical study coordinators across the Czech Republic.

Currently, MOÚ initiates approximately 25 new phase I-III clinical trials for the treatment of solid tumours each year, involving around 300 patients annually. Since 2012, MOÚ has also had a clinical trial unit for phase I studies, and in 2022, it obtained the SÚKL certificate for conducting first-in-human clinical trials.

More information about us can be found at mou.cz and mou.cz/klinicke-studie/t1520, email studie@mou.cz.

 

University Hospital Brno – Unit of the Deputy Director for Science and Research

 FN Brno is the second largest healthcare facility in the Czech Republic and a hospital of European importance, as evidenced, among other things, by its participation in six European Reference Networks (ERN). Since 2012, FN Brno has been registered in the Register of Research Organisations and since 2015 has been involved in the activities of the research infrastructure supporting academic clinical trials CZECRIN. It also cooperates with CEITEC and RECETOX in the field of applied and, to a lesser extent, basic research.

Science and research at the Brno University Hospital is related to its core business, i.e. healthcare, and thanks to this it takes advantage of the unique availability of patient data and clinical procedures that are essential for clinical research projects, including clinical trials. The Clinical Trials Department (OKS), which is part of the Unit of the Deputy Director for Science and Research, provides administrative and coordination support for the implementation of clinical trials at individual clinics of the Brno University Hospital. It participates in the preparation of contracts and, for ongoing clinical trials, the team of study coordinators of the OKS is involved in all phases of their implementation. More than 100 new applications for clinical trials, including academic trials, are processed annually at FN Brno. These are now also increasingly becoming part of grant and other research projects. Approximately 70 new clinical trials are initiated annually at FN Brno.

More information about us can be found at: www.fnbrno.cz and https://www.fnbrno.cz/utvar-namestka-pro-vedu-a-vyzkum/t4557

 

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.

To learn more, visit iqvia.com.

International Clinical Research Center (ICRC) saw a successful start of the year 2023 welcoming Dr. Adam Williamson aboard. A renowned neuroscientist, who just received a prestigious ERC Consolidator grant, opens a new Neuromodulation Technology research team in the ICRC. He will investigate methods of activating the central and peripheral nervous system to define promising treatment options for diseases such as bowel inflammation, epilepsy, and neurodegenerative disorders.

As Dr. Williamson explains: “I focus on non-invasive deep brain stimulation, primarily in epilepsy. We utilize electrodes placed on the skin which emanate electric fields. These electric fields combine in space, at deep brain regions, far below the skull and activate neurons to create desired brain reactions, for example the suppression of pathological epileptic activity in patients with epilepsy or the enhancement of memory retrieval in healthy participants during cognitive tasks.”

Adam Williamson (Photo by the ICRC)

A Canadian, who studied theoretical Electrical Engineering in Texas, received his PhD at the University of Ilmenau, Germany. He has worked in Sweden at the prestigious Karolinska Institutet and other universities. His last posting before coming to Brno was with Inserm in France. Starting as an engineer, he gradually became a neuroscientist with the ability to apply new technologies to clinical research.

His research has been widely supported by the European Research Council (ERC) grants under the EU’s Horizon Europe programme. He is a recipient of a total of four ERC Grants (ERC Starting Grant in 2016, ERC Proof-of-Concept in 2020, ERC Proof-of-Concept in 2022 and ERC Consolidator in 2023). The last two ERC grants are now being transferred to the ICRC for implementation, with the latter entitled “Epilepsy Treatment Using Neuromodulation by Non-Invasive Temporal Interference Stimulation” (EMUNITI).  Among the considerable competition, he ranked alongside 321 researchers, who have won 2022 ERC Consolidator Grants, dividing the total €657 million. The grant promises a five-year long support of the research. Dr. Williamson is now creating his new team entitled “Neuromodulation Technology” for which he has started recruiting PhD students, postdocs, and technicians.

“I am delighted that we have been able to attract such an eminent foreign scientist to the ICRC. Having an ERC grant holder is both a privilege and commitment for us – to provide his team with a supportive environment. The prestige for our institution is comparable to Michelin star restaurants, with top level gastronomic experience and best chefs being equal to cutting-edge research and top scientists”, comments prof. Irena Rektorová, the Head of ICRC, on the recent successful partnership. Dr. Williamson follows: “I am very impressed with the staff and support at ICRC every day. Prof. Rektorová has created an atmosphere which is extremely effective and well-organized for top-level clinical research. I suspect to see many more ERC holders coming to Brno in the future.”

Shortly after his arrival, the new scientist has also been welcomed by the Mayor of the City of Brno, Mrs. Markéta Vaňková, at the yearly Meet the Mayor event for new foreign talents from local institutions and companies. He will conduct his research in collaboration with the research group of Assoc. professor Eric Glowacki at CEITEC VUT, researchers from the Neuroscience Program at CEITEC MU, and colleagues from the 1^st Department of Neurology, the 2^nd Department of Internal Medicine, and the 1^st Department of Internal Cardio-angiology of St. Anne’s University Hospital Brno and the Faculty of Medicine of Masaryk University. For the moment, he is slowly settling in the city, discovering its beauties. “Tatarák is amazing!”, he concludes.

Meet the Mayor event, 3 February 2023 (Photo by the City of Brno Municipality)

Author: Marta Vrlová, M.A., MPH, Senior PR Specialist ICRC, marta.vrlova@fnusa.cz.
Contact for media: Ing. Jiří Erlebach. Head of PR and Marketing, Spokesperson, FNUSA, +420 543 182 006. jiri.erlebach@fnusa.cz.

The ERC and grant options

The European Research Council, set up by the European Union in 2007, is the European funding organisation for excellent research, funding creative researchers to run projects based across Europe. The ERC offers four core grant schemes: Starting Grants, Consolidator Grants, Advanced Grants and Synergy Grants. With its additional Proof of Concept Grant scheme, the ERC helps grantees to bridge the gap between their pioneering research and early phases of its commercialisation. The ERC is led by an independent governing body, the Scientific Council. Since 1 November 2021, Maria Leptin is the President of the ERC. The overall ERC budget from 2021 to 2027 is more than €16 billion, as part of the Horizon Europe programme, under the responsibility of the European Commissioner for Innovation, Research, Culture, Education and Youth, Mariya Gabriel. For more information follow https://erc.europa.eu.

International Clinical Research Center

We are a modern center of scientific excellence based in Brno, Czech Republic, oriented on preclinical and clinical research, mainly in the fields of cardiology, neurology and oncology. We search for new diagnostic and therapeutic methods, technologies and drugs. By putting our findings into practice, we improve patient care and quality of life. In July 2022, we became a joint workplace of St. Anne’s University Hospital Brno (FNUSA) and the Faculty of Medicine of Masaryk University (LF MU) in Brno. We develop relations and cooperation with other key players, both internationally and within our region. Our activities are included in the action plan for implementation of #brno2050 strategy, thus shaping the future of #brnoregion. Visit www.fnusa-icrc.org for more details about us.

The project entitled “Unveiling the molecular determinants of aging to design new therapeutics (MAGNET)” has now successfully concluded at the International Clinical Research Center (ICRC) in Brno. Its main focus was research of selected ageing-associated diseases, understanding their mechanisms and finding potential targets for their treatment. The project, which gained great support from the European funds, attracted to Brno a number of both junior and established researchers, headed by Dr. Manlio Vinciguerra.

The main research objectives of the project consisted in unveiling the role of epigenetics, mechanosensors, immune response, intracellular transport, and mitochondrial dysfunction in the pathogenesis of aging-associated diseases. The specific problems targeted by the research activities were liver diseases such as hepatocellular carcinoma, innate immunity defects, cardiovascular and neurodegenerative pathologies.

The project was awarded over 177,5 mil. CZK in 2016 by the Ministry for Education, Youth and Sports of the Czech Republic (MŠMT). Funded through the Operational programme Research, Development and Education (in Czech OP VVV), it aimed at attracting a renowned international scientist, Dr. Manlio Vinciguerra, to establish his research group at the ICRC. At the time Dr. Vinciguerra was a Senior Scientist working at the University College London (UCL), London United Kingdom.

“The funding from the MŠMT through the OP VVV program helped us to significantly advance the understanding of aging-associated pathologies, which represent a true burden to the society” says Manlio Vinciguerra, the coordinator of the project. “It gave me the chance to join a very vibrant scientific environment at the ICRC and to establish my research group. I am extremely thankful for this opportunity” he continues.

The team employed other Principal Investigators of the ICRC, i.e. Irena Koutná, Giancarlo Forte, Gorazd Bernard Stokin, Jan Frič and Jaeyoung Shin; and attracted promising young researchers and students of more than 10 nationalities. Thanks to the available funds, we were also able to send our Ph.D. students for internships abroad.

“The international nature of the research team created thanks to the OP VVV funding was really a game changer. It created a lively and varied environment which helped the cross-contamination of scientific ideas. The result of this process has been excellent science.” comments Giancarlo Forte, who is also the Head of the Center for Translational Medicine at the ICRC, where the research was performed.

Focused on excellent and clinically meaningful research, the project led to disclose the role of histone protein macroH2A1 as a determinant of liver disease progression and of hepatocellular carcinoma aggressiveness, making it a potential target for future treatments. Moreover, the project allowed for the identification of novel predictive markers for heart failure, the proteins Yes Associate Protein (YAP) and heterogeneous nuclear ribonucleoprotein C (hnRNPC), together with providing the first multiscale map of the human failing heart. Additionally, thanks to the financial support of MAGNET project, scientists at the ICRC described how chronic inflammatory signalling affect the extracellular matrix and also the phenotype of immune cells.

“A number of young and established researchers participated in this very successful project. It was an honour for our institution to host it. The scientific objectives reached are truly remarkable” stress Prof. Irena Rektorová, the Head of ICRC.

These results were published in prestigious peer-reviewed international journals, like Hepatology, Science Translational Medicine, Nature Communications, Circulation Research, EMBO Molecular Medicine, Theranostics, iScience, GeroScience, Lancet Health Longevity, Acta Neuropathologica Communications and others. In terms of numbers, there were more than 100 publications affiliated to the project, with 50 % of them in Q1 journals. First quartile representing the best journals according to series of metrics.

“The project entailed the use of tissues and cells harvested from patients hospitalised at the premises of St. Anne’s University Hospital Brno (FNUSA), so that the results have a concrete translational potential” says Ing. Vlastimil Vajdak, director of FNUSA hospital.

MAGNET project also helped to establish the Cell and Tissue Engineering Facility (CTEF) at the ICRC, a unit endowed with ISO 9001 certification (quality management system) and GMP manufacture permit which manufactures advanced therapy medicinal products (ATMPs) including cell therapy and tissue engineered products.

The funding also allowed establishing or consolidating prestigious international collaborations with UCL (UK), the European Institute for Systems Biology and Medicine (EISBM, France), the University of Barcelona (Spain), the University of Geneva (Switzerland), the University of Southern California (USA), the University of Porto (Portugal), the University of Perugia (Italy).

Supported by the European Regional Development Fund – Project MAGNET
(No. CZ.02.1.01/0.0/0.0/15_003/0000492).

 

Nature cannot do without enzymes – proteins that speed up chemical reactions in all living organisms. For example, we owe our beer and wine to enzymes; we wouldn’t enjoy hard cheeses and, in principle, wouldn’t do laundry without them. But people also use enzymes in biomedicine, industry, and environmental protection. Unfortunately, relatively few enzymes perform optimally, so scientists have been working for decades on searching for more efficient enzymes. In doing so, they keep running into a fundamental question: Is it better to modify existing enzymes through protein engineering or to search for new ones in nature’s vast diversity?

Researchers from the Loschmidt Laboratories at RECETOX, Faculty of Science, Masaryk University and the International Clinical Research Center (ICRC), in collaboration with colleagues from ETH Zurich and the University of Greifswald, decided to go down the route of searching for new enzymes. They published the results of their six-year research project in the international prestigious journal Chem Catalysis. Their aim was to find more efficient variants of an enzyme family that can degrade halogenated hydrocarbons polluting the environment. The search began in genomic databases, which currently contain hundreds of millions of gene sequences that encode previously unknown proteins. Using the in-house web tool EnzymeMiner, they were able to select the most promising candidates from this plethora of sequences. “You could compare it to finding needles in a haystack. With EnzymeMiner we can distinguish the needle from the straw very well. However, in the next step we need to find out if the selected needles are sharp enough – this means to experimentally verify that the selected enzymes are fast enough,” said Michal Vašina, the first author of the study.

Therefore, the researchers then prepared these selected candidates in the laboratory and studied their properties using two microfluidic platforms – modern technologies that can handle miniature sample volumes and save time. The first platform, MicroPEX, was used by the researchers to systematically characterize enzymatic reaction rates, while the second platform, KinMAP, gave them insight into the actual mechanism of enzymatic reactions. “The savings in time and money are tremendous. Thanks to this method, we can measure the same amount of data in a single week that would take months to obtain with conventional technologies,” said the microfluidic expert Zbyněk Prokop.

Coming back to the question from the beginning of the article, whether it is better to discover or engineer new enzymes, this scientific study gives a clear answer. Historically, the first enzymes degrading halogenated hydrocarbons were identified more than 30 years ago, while protein engineering has been used for their modification for 25 years. During this time, the properties of twenty-five discovered and more than one hundred modified enzyme variants have been described. When comparing the data obtained, the researchers found that the newly obtained enzymes had better properties than any previously discovered or modified enzyme from the same family.

So how to get more efficient enzymes? Based on their experience, the scientists in the Loschmidt Laboratories answer: “Let’s not underestimate nature. Thanks to its diversity, it has an arsenal of effective enzymes just waiting to be discovered!”

Publication:

https://doi.org/10.1016/j.checat.2022.09.011

 

 

 

 

 

The synergy of advanced bioinformatics and microfluidics helps to find efficient enzymes for recy-cling chemical synthesis intermediates, degrading environmental pollutants, or preparing active pharmaceutical ingredients.

Scientists from several research teams at the International Clinical Research Centre (ICRC), a joint facility of the Masaryk University Faculty of Medicine and St. Anne’s University Hospital in Brno, focused on microbial infections and Alzheimer’s disease. The link between the two has been demonstrated in many studies, and the research focused on the frequency of the most common viral and bacterial pathogens in the brains of Alzheimer’s patients.

The paper, entitled “Increased occurrence of Treponema spp. and double-species infections in patients with Alzheimer’s disease,” was published in the scientific journal Science of The Total Environment (IF – 10.75).

Alzheimer’s disease (AD) is an irreversible, progressive neurodegenerative pathology. It accounts for 60-80% of cases of dementia. Dementia is a general term encompassing memory loss and the gradual decline of other cognitive abilities, often severe enough to interfere with an individual’s daily life and independence. The origin of Alzheimer’s disease is not yet fully understood. The disease is characterised by a pathological cascade of protein clotting. One of these is amyloid, whose function is to protect the brain from infectious agents, i.e. viruses or bacteria. There are theories that the action of a particular virus or pathogen may cause this protein to clot more than is permissible and thus trigger the pathological cascade.

For the detection of five bacterial and five viral pathogens, a multiplex PCR assay kit has been developed in collaboration with BioVendor, where all of the aforementioned pathogens can be detected simultaneously. “Although the link between microbial infections and Alzheimer’s disease has been demonstrated in many studies, the contribution of pathogens to the onset of Alzheimer’s disease remains unclear,” said the first author of the paper, Dr Michal Nemergut from the Loschmidt Laboratories of the MU Faculty of Science and the ICRC. “Therefore, we investigated the frequency of the ten most frequently reported viral (HSV-1, EBV, HHV-6, HHV-7, CMV) and bacterial (Chlamydia pneumoniae, Helicobacter pylori, Borrelia burgdorferi, Porphyromonas gingivalis, Treponema spp.) pathogens in serum, cerebrospinal fluid and brain tissue of Alzheimer’s disease patients.”

Serum and liquor samples from 50 patients with Alzheimer’s disease and 53 control subjects without cognitive deficits were used. The samples and data were provided by the Czech Brain Aging study – a national aging study led by Kateřina Sheardová, MD, and Prof. Jakub Hort, MD. A significantly higher frequency of patients with Alzheimer’s disease who were positive for Treponema spp. was observed compared to controls (62.2% vs 30.3%). Furthermore, a significantly higher incidence of cases with two or more concurrent infections was confirmed in patients with Alzheimer’s disease compared to controls (24% vs 7.5%). The studied pathogens were detected with comparable frequency in serum and cerebrospinal fluid. In contrast, Borrelia burgdorferi, human herpesvirus 7 and human cytomegalovirus were not detected in any of the studied samples.

This study provides further evidence of an association between microbial infections and Alzheimer’s disease. “The results show that parallel analysis of multiple pathogens and detection of their occurrence from multiple different biological samples provides interesting additional information, and this methodology should be considered for future studies working with this hypothesis in the context of Alzheimer’s disease.” said Katerina Sheardová, MD.